Kornimate/medical-research-clean huggingface dataset:
fastigial nucleus stimulation for coronary heart disease

Conditions: Coronary Disease

Summary: to observe the effects of fastigial nucleus stimulation on serum inflammation, oxidative stress related factors, cardiac autonomic function and prognosis in patients with coronary heart disease

in recent years, with the improvement of the material living standards of the investigators residents and the change of working lifestyle, the prevalence and mortality of coronary heart disease (chd) in urban and rural residents in china have increased year by year. according to statistics, the number of patients with coronary heart disease in china is currently 11 million. coronary heart disease has become a major health problem in china. at present, it is found that inflammatory reaction and oxidative stress factors are involved in the occurrence and development of coronary heart disease, and their indicators such as heart rate variability are related to the prognosis of coronary heart disease. fastigial nucleus stimulation (fns) has been widely used in the treatment of various diseases such as cerebrovascular disease, migraine, and eye diseases. the study found that fns can reduce inflammatory cytokines and oxidative stress factors in ischemic myocardium and improve heart rate variability in rats with myocardial infarction. the aim of this study was to investigate whether fns can improve the aforementioned indicators and clinical outcomes in patients with coronary heart disease.

Eligibility criteria:
inclusion criteria: * coronary angiography was performed after admission, and coronary heart disease was diagnosed (coronary angiography showed at least one coronary artery with a diameter reduction of ≥50% from more than two different angles) * patients and their families agreed and signed informed consent exclusion criteria: * severe chronic heart failure, and lvef \<30% * body temperature \> 38 ° c and / or combined with severe infection in any system * severe liver and kidney dysfunction * malignant tumor * autoimmune diseases * high blood pressure and diabetes with severe comorbidities * use of implantable electronic devices * intracranial implanted vascular stents * surface treatment electrode conductive materials allergic or mastoid skin lesions

Keywords: coronary heart disease fastigial nucleus stimulation inflammatory factors
the role of simvastatin in the epithelial-mesenchymal transition process of breast cancer

Conditions: Triple Negative Breast Cancer; Chemotherapy Effect; Simvastatin Adverse Reaction

Summary: introduction: most cases of triple negative breast cancer (tnbc) have a high proliferation rate. tnbc is associated with a poor prognosis, a high recurrence rate, and a high incidence of distant metastases. the epithelial-mesenchymal transition process (emt) plays an essential role in the metastatic process. emt markers were also more abundant in tnbc and contributed to a poorer tnbc prognosis. as an important emt marker, the increased expression of vimentin also contributed to the increase in tnbc aggressiveness and resistance to chemotherapeutic agents. through the mechanism of action in inhibiting the mevalonate pathway, statins can help inhibit the emt process in metastases. notably, simvastatin promotes the down-regulation of vimentin in breast cancer cells. the combination of statins and neoadjuvant chemotherapy (nac) improves the cancer patient's response. this study is expected to evaluate the role of a combination between nac and simvastatin on therapeutic response in tnbc patients through vimentin expression. methods: this study is a double-blind, randomized, placebo-controlled trial conducted in dr. cipto mangunkusumo national central general hospital. an expected total of 26 tnbc patients will be assessed for eligibility and asked for informed consent. patients with the plan to have act (doxorubicin hydrochloride, cyclophosphamide, paclitaxel) chemotherapy regimen will receive either a combination of act-simvastatin (40 mg/day) or act-placebo. the biopsy will be taken pre-nac to make the histopathological diagnosis and examine the expression of vimentin. patients will be evaluated for adverse effects reaction every cycle and the clinical response after 8 cycles. the post-intervention biopsy will be conducted after the cycle finish. the pathological response and vimentin expression will be reviewed from the obtained samples.


Eligibility criteria:
inclusion criteria: 1. female patients with advanced breast cancer (locally advanced and distantly advanced) with triple-negative molecular type confirmed by biopsy and immunohistochemical examination. 2. the patient planned to receive 8 cycles of ac-t chemotherapy. 3. patient age \> 18 years. 4. willing to participate in research by signing informed consent. exclusion criteria: 1. the patient is pregnant or breastfeeding. 2. patients who have received chemotherapy or are on simvastatin therapy. 3. allergy to statins.

Keywords: vimentin simvastatin epithelial-mesenchymal transition neoadjuvant chemotherapy clinical response pathological response
lace up and move: structured after school intervention for hispanic and african american youth

Conditions: Childhood Obesity; Obesity; Physical Activity

Summary: the purpose of this study is to test the efficacy of lace up and move (luam), a structured after-school exercise intervention, designed to increase moderate-to-vigorous physical activity (mvpa) and enhance sleep quality among hispanic and african american (aa) boys and girls.

this study uses a randomized comparison-group pre-post-test design. overall objectives of luam are to: (1) to increase the percentage of youth who meet 60 minutes of daily mvpa per week; (2) to improve the quality of sleep patterns (i.e., sleep efficiency and duration); and (3) to reduce percent body fat (%bf). it is hypothesized that compared to the control group (cg) participants, the experimental group (eg) participants will exhibit: (a) greater increase in percentage of children who meet 60 minutes of daily mvpa per week; (b) greater increase of sleep efficiency and duration; and (c) greater decrease in sleep latency and (d) greater decrease in %bf.

Eligibility criteria:
inclusion criteria: * child and at least their mother \[or one member of the family\] must be of hispanic or african american descent * child must have no physical disability or medical conditions that interfere with their participation in the exercise program exclusion criteria: * neither child nor parental guardians is of hispanic or african american descent * child is not between the ages of 9-14 years * child is pregnant or physically unable to participate in the exercise program.
disease trajectories and anti-cytokine response signatures in atopic dermatitis and psoriasis

Conditions: Atopic Dermatitis; Psoriasis; Healthy

Summary: the clinical study investigates the long-term course of disease in patients with chronic inflammatory skin diseases (atopic eczema and psoriasis) and the impact of tarheted therapies on the clinical and molecular level. for this purpose, patients are asked to take part in regular examinations and data collections, and to donate biomaterials (blood, skin biopsies, skin swabs, tape strips, stool samples). blood samples are used to analyze inflammation messengers. punch biopsies from lesional and non-lesional skin areas are used to analyze gene expression. tape strips are pieces of transparent adhesive tapes to strip off most of the horny layer that will be used to examine mrna and protein expression. the skin smears are superficial smears of three areas of skin with cotton swabs, which are used to examine bacteria on the skin. overall, the study will help to monitor the disease course clinically and on the molecular level in participating patients for at least ten years and to collect information about the impact of various external factors including treatments. the study has no effect on the therapies of the disease, it serves only the accompanying data collection

atopic dermatitis and psoriasis are the most common chronic inflammatory skin diseases in dermatology. due to genetic predispositions, inflammatory changes of the skin occur. the specific mechanisms are only partly understood for both diseases and targeted therapies are established in psoriasis therapy and are becoming available for atopic dermatitis. in order to better understand the course of the disease and to characterize the changes in the inflammatory mechanisms during the course of the disease and under the influence of external factors such as therapies, longitudinal prospective studies are needed to evaluate clinical data and biological samples. this study investigates long-term clinical and epidemiological data from affected patients, as well as biological samples, including blood samples, skin biopsies, non-invasive skin swabs for microbiome detection, and tape strips for the molecular characterization of the disease. data collection and biosampling will be done during routine visits, typically at week 0, 2, 12 and 52.

Eligibility criteria:
inclusion criteria: * patients with a clinical diagnosis of atopic dermatitis, psoriasis or autoimmune skin disease * written informed consent obtained from the subject exclusion criteria: * patients who decline participation in patients\<18 years of age no biopsies will be taken

Keywords: disease progression disease course immunological characterization
a compassionate access protocol for those patients who have completed a4001029

Conditions: HIV

Summary: this is a compassionate study to provide continued access to maraviroc for only those subjects completing study a4001029 who are showing clinical benefit. assessments of safety and tolerability of maraviroc when added to obt will be continued.


Eligibility criteria:
inclusion criteria: * patients having completed study a4001029 in canada and still deriving clinical benefit. exclusion criteria: * none

Keywords: compassionate hiv ccr5
to investigate the efficacy and safety of vardenafil in men with erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: to investigate the efficacy and safety of vardenafil in men with erectile dysfunction.


Eligibility criteria:
inclusion criteria: * men 21 years or above with ed for more than 6 months with normal libido and stable heterosexual relationship of at least 6 months * having at least a 50% failure rate of sexual intercourse attempts during the run-in phase exclusion criteria: * subjects with penile abnormalities, hypogonadism, history of unstable angina pectoris for 6 months or less, myocardial infarction, life threatening arrhythmia and history of unresponsiveness to sildenafil were excluded. * diabetic subjects with hemoglobin a1c (hba1c) more than 12% were also excluded. * subjects could not be on androgens/anti-androgens or alpha blockers.

Keywords: erectile dysfunction sexual dysfunction
accuracy and stability of a new automatic knee arthrometer in diagnosing acl rupture

Conditions: Knee Ligament; Laxity

Summary: we introduced an automatic knee arthrometer (aka) and aimed to evaluate the repeatability and effectiveness thereof in diagnosing acl rupture compared with the kt-2000.

the aka was compared to the kt-2000 at 134 n in this study, the anterior displacement and difference of both knees of every subject were measured. the first protocol was designed to evaluate examiner effect (level of experience) and contralateral-side effect (left or right knee) in a single healthy subject, ten times, on ten consecutive days. the second was to compare the stability in 20 healthy subjects, with a single experienced examiner. third, we recruited 200 acl rupture and 200 healthy subjects as contrast to compare the accuracy of the devices in diagnosing acl rupture.

Eligibility criteria:
inclusion criteria: * patients with acl rupture from our institution were included. all patients were diagnosed by sports medicine specialists based on clinical manifestation, combined with imaging examinations, and hospitalized for further surgery. exclusion criteria: * patients aged \ 45 years, with combined multiple knee ligament injury combinations, and/or limited range of motion of the knee (unable to flex to 20-30°)
pilot study of irreversible electroporation (ire) to treat early-stage primary liver cancer (hcc)

Conditions: Carcinoma, Hepatocellular

Summary: the purpose of this study is to evaluate the safety and efficacy of the nanoknife ledc system for the treatment of early-stage hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * hcc diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection or transplantation, * have at least one, but less than or equal to 3 tumors, * of the tumour(s) identified, each tumor must be ≤ 3 cm in diameter, * child-pugh class a, * eastern cooperative oncology group (ecog) score of 0, * american society of anaesthesiologists (asa) score ≤ 3, * a prothrombin time ratio \> 50%, * platelet count \> 50x109/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * are able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * eligible for surgical treatment or transplantation for hcc, * presence of vascular invasion or extrahepatic metastases, * received previous treatment for hcc, * hcc developed on an already transplanted liver, * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: hcc hepatocellular carcinoma early stage prospective multicenter irreversible electroporation (ire) electroporation low energy direct current ledc nonthermal ablation ntire (nonthermal ire) ablation soft tissue
postoperative neurocognitive dysfunction after major abdominal surgery (pandaman)

Conditions: Elective Major Abdominal Surgery

Summary: predisposing and precipitating factors for perioperative delirium for the elderly remain elusive. this research will be conducted to determine risk factors of postoperative delirium.

this study intends to include 500 participants over 65 years old undergoing elective abdominal major surgery. the primary outcome is incidence of delirium at 7 days postoperatively, and the secondary outcomes include preoperative sleep disorders(athens in-somnia scale, ais), postoperative cognitive impairment (abbreviated mental test score, amts), postoperative pain (nrs pain score), incidence of significant postoperative complications, length of hospital stay, and serum biomarkers levels.

Eligibility criteria:
inclusion criteria: 1. 65 to 90 years old to receive elective major abdominal surgery (expected operation time over 2 hours); , 2. american society of aneshesiologists（asa）physical status i-iii; exclusion criteria: 1. mini-mental state examination (mmes) score \< 15; 2. renal failure (requiring dialysis) or liver failure (child-pugh score \> 5); 3. severe impairment due to structural or hypoxic brain injury, more than 2 days in icu one month before surgery; 4. underwent major heart, lung or abdominal surgery within 1 year; 5. positive for severe acute respiratory syndrome coronavirus 2 (sars-cov-2) or symptomatic (e.g. fever, cough, loss of taste/smell); 6. the cognitive assessment cannot be completed because the subject is blind, deaf, or unable to communicate in the local language; 7. long-term follow-up unavailable (homelessness, active psychosis or substance abuse).
stress reduction after use of a haptic vibrotactile trigger technology patch: analysis and assessment

Conditions: Stress; Anxiety

Summary: the purpose of this research study is to collect subject perceptions or feelings about their treatment. participation includes a survey from individuals who are receiving a stress or anxiety-relieving topical patch \[super patch peace patch with haptic vibrotactile trigger technology (vtt)\] and assigned to a treatment group or given a sham patch, assigned to the control group, to address symptoms or stress and anxiety symptoms using validated scales \[for example, the perceived stress scale (pss) or medical outcomes study short form-20 (sf-20)\].

this minimal risk observational study, will evaluate an over the counter (otc) non-invasive, non- pharmacological patch (super patch peace patch; the super patch company ltd llc., srysty holding co., toronto, canada) that is embedded with a proprietary sensory pattern and incorporates haptic vibrotactile trigger technology (vtt) and designed to trigger neural pathways and circuits associated with stress, anxiety, and other cortical networks, with other study participants who receive an 'inactive' (sham) patch without the embedded vtt technology. the sensory patterns within the active patches are in close symmetry between known eeg patterns and their role in modulating eeg and neuronal circuits within higher brain centers.

Eligibility criteria:
inclusion criteria: 1. ages 18 to 85, inclusive 2. able to provide written informed consent 3. have received a peace patch from their treating clinician if in treatment group. 4. is a patient who has been diagnosed with experienced stress or anxiety related issues. 5. have received a sham patch if assigned tot eh control group exclusion criteria: 1. use of drugs of abuse (illicit or prescription) 2. pregnancy 3. existing or planned implantation of pacemaker or other electrical devices

Keywords: stress anxiety superpatch peace patch haptic vibrotactile haptic technology vtt
open-label long term (52 weeks) safety and tolerability of agomelatine sublingual tablets in major depressive disorder (mdd)

Conditions: Major Depressive Disorder

Summary: the study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (ago178) in patients with major depressive disorder over a 52-week open-label phase. cohort i is restricted to include patients who have completed a previous novartis agomelatine (178c) double-blind study. cohort ii will include de-novo patients (those who did not participate in a previous agomelatine 178c study) and will only be open for a limited time span ranging from approximately june to sept 2010, at which point this cohort ii will be closed to enrollment.


Eligibility criteria:
inclusion criteria: key inclusion criteria cohort i: * documentation of completion of a novartis ago178c double-blind study in mdd patients. * male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for double-blind study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the double-blind study). * female patients should continue to use effective contraception as defined in double-blind study protocol. inclusion criteria: key inclusion criteria cohort ii: * male and female adults, 18 through 70 years of age, inclusive. * diagnosis of mdd, single or recurrent episode, according to dsm-iv criteria. * current episode ≥4 weeks. * cgi-severity score ≥4 at screening and baseline. exclusion criteria: key exclusion criteria cohort i: * concomitant use of fluvoxamine. * any significant medical condition that emerged during double-blind phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator. exclusion criteria: key exclusion criteria cohort ii: * history of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder. * any other current axis i disorder other than mdd which is the focus of treatment. * substance or alcohol abuse in the last 30 days, dependence in the last 6 months. * prior exposure to agomelatine. * female patients of childbearing potential who are not using effective contraception. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: agomelatine major depressive disorder mdd depression
life-stress interview for women with chronic urogenital pain conditions

Conditions: Chronic Urogenital Pain

Summary: the goal of this study is to test the efficacy, feasibility, and acceptability of providing an experiential assessment interview that targets health, and emotional and stressful experiences in a tertiary care setting specializing in women's urology.

in this randomized, controlled trial, the investigators will compare an interview condition to a wait-list control condition. the investigators hypothesize that helping individuals identify the links between their stress, emotions, and physical symptoms will likely increase their awareness and endorsement of the link between stress and physical symptoms, including a willingness to engage in stress management techniques. it is also expected that helping raise an individual's awareness about their symptoms, followed by an experience and expression of unexpressed emotion is likely to influence their physical and psychological well-being.

Eligibility criteria:
inclusion criteria: * participants must have a chronic urogenital pain condition exclusion criteria: * non-english speaking * unable to read * psychosis * dementia * mental impairment

Keywords: chronic pelvic pain interstitial cystitis vulvodynia dyspareunia pelvic floor dysfunction emotional processing